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Preliminary Phase I/II Data Show Lucentis(TM) in Combination With Visudyne(R) Maintained or Improved Vision in Approximately 90 Percent of Patients With Wet Age-Related Macular Degeneration.

Publication: PR Newswire
Publication Date: 31-MAY-05 		Format: Online - approximately 1339 words
Delivery: Immediate Online Access

Article Excerpt
SOUTH SAN FRANCISCO, Calif., May 31 /PRNewswire-FirstCall/ -- Genentech, Inc. announced today that a single-masked Phase I/II clinical study of the investigational drug Lucentis(TM) (ranibizumab) met its primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration (AMD) when used in combination with verteporfin (Visudyne(R)) photodynamic therapy (PDT). Approximately 90 percent of patients maintained or improved vision (defined as a loss of less than 15 letters in visual acuity) when treated with the combination of Lucentis and PDT compared to approximately 68 percent of those treated in the control arm of PDT alone (p = 0.0003). Patients treated with Lucentis plus PDT at 12 months had, on average, a significant improvement in visual acuity compared to visual acuity at study entry, an important secondary endpoint, while the PDT-alone group demonstrated a decrease in mean visual acuity from baseline to 12 months. One-year data from the trial will be presented at the 23rd Annual Meeting of the American Society of Retina Specialists (ASRS), July 16 to 20 in Montreal, Canada.

A preliminary analysis of the data showed there was an increased risk of the serious ocular adverse event uveitis in patients treated with Lucentis in combination with PDT...

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